Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2017-01-12

Brief Summary

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This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.

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Detailed Description

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In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.

Conditions

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Brain Injury Central Nervous System Degenerative Disorder Central Nervous System Infectious Disorder Central Nervous System Vascular Malformation Hemorrhagic Cerebrovascular Accident Ischemic Cerebrovascular Accident Primary Brain Neoplasm Brain Cancer Brain Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ferumoxytol group

All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.

Group Type EXPERIMENTAL

Ferumoxytol

Intervention Type DRUG

Undergo ferumoxytol-enhanced MRI

Tissue Analysis

Intervention Type OTHER

Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Magnetic Resonance Imaging

Intervention Type PROCEDURE

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Interventions

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Ferumoxytol

Undergo ferumoxytol-enhanced MRI

Intervention Type DRUG

Tissue Analysis

Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Intervention Type OTHER

Magnetic Resonance Imaging

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Intervention Type PROCEDURE

Other Intervention Names

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Feraheme FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE Magnetic Resonance Imaging Scan MRI

Eligibility Criteria

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Inclusion Criteria

* Any patient with suspected brain tumor diagnosed by MRI
* Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases)

Exclusion Criteria

* Informed consent cannot be obtained either from the patient or legal representative
* Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study
* Contraindication to MRI (metal implants)
* Hemosiderosis/hemochromatosis
* Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned)
* Known hypersensitivity to Feraheme (ferumoxytol) or any of its components
* Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No